Research

Strategy

The M-CERSI creates new mechanisms for scientific exchange, education and training, as well as regulatory science research. The center brings together diverse thoughts and ideas around emerging technologies and methodologies for regulatory science. The sum of these interwoven activities is a vibrant, cutting edge center that stimulates innovative thought, disseminates understanding of regulatory science and practices, and generates new knowledge in support of the FDA’s fundamental mission -- to promote and protect the public health -- under current priorities and initiatives.

Visiting Scientists

A critical component of center success is establishing, promoting, and facilitating two-way connections between UM and FDA staff. The M-CERSI will invite visiting scientists from the FDA and from industry to engage with the new Center and to engage in scientific exchange. Also, M-CERSI will provide continuing education (CE) training for FDA personnel.

Creating New Opportunities for Collaborative Regulatory Scientific Research

Center-Wide Regulatory Science Activities – The M-CERSI will execute in parallel three regulatory science projects reflecting the collective strengths of UM campuses in College Park and in Baltimore. The Scientific Exchange, Research and Training Activities for each project are managed by project leaders.

M-CERSI sponsors a small regulatory science research component that is unattached to its projects. Several small Innovation Awards will help build its program in the future.

Specific Regulatory Science Activities - M-CERSI focuses on three project areas, each corresponding to an FDA-specified focus. Each major project area includes training and exchange, as well as a research component. Each major project will support at least two graduate students / fellows, who will benefit from FDA advice and guidance. The Executive Committee, comprised of UM and FDA leadership, will solicit proposals from UM faculty and develop a specific plan for each project area. In this way, priorities can be identified and appropriate investments can be made. Additionally, this will provide a mechanism for project renewal and/or new project development as the Center grows and matures.

2011-2012

Project 1 - Improving pre-clinical assessments of safety and efficacy

“Improving pre-clinical assessments of safety and efficacy” focuses on membrane transporters in drug development. Membrane transporters allow nutrients to move throughout the body, and also move drugs throughout the body. However, these doorways can be the basis for drug-to-drug interactions, where a “perpetrator drug” interferes with how a second “victim drug” normally uses a transporter. The University of Maryland is conducting experiments in collaboration with FDA scientists in order to aid FDA to develop decision trees. FDA decision trees will help industry and FDA scientists identify what membrane transporters are most important, in terms of the potential to cause drug-to-drug interactions. FDA decision trees will also provide guidance about how cell culture studies can be used to avoid or require human clinical testing, in order to advise health care professionals and patients about transporter-based drug-to-drug interactions. University of Maryland faculty contributing to the research are Drs. Yan Shu, James Polli,Peter Swaan, and Hongbing Wang.

Ensuring readiness to evaluate innovative and emerging technologies is an important goal for the M-CERSI, focusing on new technologies that will contribute to the scientific underpinning of two device-related product areas: (1) laser-based therapeutic devices; and (2) tissue engineering constructs.

Regarding the first subproject above, there is a lack of reliable, widely-accepted benchtop techniques for characterizing and assessing the sub-surface laser therapeutic dosage. As a result, the potential for understanding the device- and tissue-dependent effects, as well as laser therapy system performance, are diminished. These complicate the regulatory process and increase the burden on manufacturers to provide clinical studies to demonstrate safety and effectiveness. This project will develop and validate novel test methods that will enable rapid and reliable evaluation of laser therapy system performance and advance the innovation and translation of light-based therapeutic techniques.

The second subproject involves the creation of polymeric scaffolds that function within guided tissue regeneration strategies. These need precise control over the formative processing steps and also detailed and standardized characterization of the resulting properties. Here, we are developing methods to evaluate scaffold properties across manufacturers and between product iterations. By undertaking these studies, we anticipate the basis for standardization of scaffold characterization, in general. University of Maryland faculty contributing to the research are Drs. Yu Chen and John Fisher.

“Harnessing diverse data through information sciences to improve health outcomes” focuses on patient prescriber agreements (PPAs) of prescription opioid analgesic drugs. In recent years, FDA has started to employ strategies to reduce misuse and abuse of opioid pain medications. PPAs are contracts between prescribers and their patients to at least list expectations of each the prescriber and the patient. With pain drugs a serious health issue, and opioids having abuse potential, there are several PPAs for various opioid pain medications. These PPAs often outline terms of treatment, patient responsibilities, education issues, addiction treatments, emergency issues, goals, and prescription limitations. University of Maryland faculty are conducting a review of PPAs currently in use, determining which healthcare professionals are using PPAs and the conditions of use. The researchers are also examining different formats and types of PPAs. University of Maryland faculty contributing to the research are Drs. Frank Palumbo, Francoise Pradel, Gail Rattinger, and Ilene Zuckerman.

2013-2014

M-CERSI Innovation Awards

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) has recently awarded two Innovation Awards, and two Innovations in Minority Health Awards.

The aim of M-CERSI Innovation Awards is to promote innovations in FDA training or research that, through well defined outcomes, will foster the development of regulatory science. M-CERSI Innovations in Minority Health Awards are similar to Innovation Awards and additionally aim to address racial and ethnic health disparities.

The two Innovation awardees for 2013-2014 are:

Dr. Michael Zachariah, Department of Chemical and Bimolecular Engineering and Department of Chemistry and Biochemistry.
"Absolute Protein and Protein Aggregate Concentration Measurement"
In this proposal we are going to demonstrate electrospray differential mobility analysis (ES-DMA) as a tool to quantify protein aggregation, and as an absolute number concentration primary standard for protein with a projected uncertainty of <5%.

Dr. Peter Swaan and Dr. Hongbing Wang, University of Maryland Baltimore, School of Pharmacy.
"Development of Computational Models to Predict Drug-Induced Liver Injury (DILI)"
In this study we aim to develop and validate models that integrate all three transporters in a web-based environment that can be accessed by investigators in academia, industry and the FDA.

The four Minority Health awardees are:

Dr. Monifa Vaughn-Cooke, Department of Mechanical Engineering
"Addressing Chronic Disease Healthcare Disparities through the Patient-Centric Design of Health Information Technology"
The proposed research introduces a new paradigm of HIT that empowers patients to be more involved in their chronic disease management through enhanced patient-provider communication and shared treatment decision making.

Dr. Julie Zito, University of Baltimore Department of Pharmaceutical Health Services Research
"Racial/Ethnic Differences in Pediatric Antipsychotic Use by FDA Labeled Status"
The aim to study antipsychotic use in youth in relation to racial/ethnic differences, insurance type, and FDA labeled indication for use.

Dr. Claudia Baquet, University of Maryland Baltimore School of Medicine
"Qualitative Focus Group Studies: Clinical Trial Participation and Biospecimen (Tissue) Donation for Research: Barriers, Willingness to Participate in Clinical Trials, Willingness to Donate to Biobanks, and Informed Consent Preferences Among Rural and Urban Residents in Maryland’s Eastern Shore, Rural Southern Maryland, and Urban Baltimore City"
This investigation will focus on underserved populations which are underrepresented in clinical trial and biospecimen donation, that is, rural and urban communities in Maryland.

Dr. Sandra Crouse Quinn, School of Public Health
“Investigating Factors Associated with Participating of Racial & Ethnic Minority Populations in FDA Regulated Research”
The aim to ensure adequate representation of minorities in industry trials of drugs and devices and to strengthen the capacity of industry investigators to recruit and retain minority participants.

M-CERSI co-director James Polli indicates “These awards reflect the great depth and scope in research at the University of Maryland that have the potential to impact medical product regulation. Furthermore, the M-CERSI program facilitates even greater scientific interactions between university and FDA staff.” “We are especially glad to be working with the FDA Office of Minority Health on some of these awards” says M-CERSI co-director William Bentley.

FDA Chief Scientist Jesse L. Goodman on the Importance of the CERSI

The Fischell Department of Bioengineering was honored to welcome FDA Chief Scientist and Deputy Commissioner for Science and Public Health, Jesse L. Goodman, M.D., M.P.H., to the 2011 Fischell Festival as our Keynote speaker. Goodman discussed what the new partnership would mean for the approval processes applied to new drugs and biomedical devices.

Goodman's address introduced guests to the FDA’s new strategic plan for advancing regulatory science, and how building partnerships with academia and industry—like the establishment of the new CERSIs with the University of Maryland and Georgetown University—will be critical to advancing its goals.

Addressing the criticisms leveled against the agency, Goodman explained how difficult its job can be. "The FDA regulates products that relate to 25% of the nation’s economy," he told the audience, "so you can see how the potential to do good in terms of promoting innovation, to do harm if you unnecessarily slow it, or to do harm if you make decisions that allow unsafe products on the market, is tremendous."

The FDA's new strategic plan and vision, Goodman explained, is to speed innovation, improve decision making, and get safe and effective products to people in need by focusing on eight key areas: Modernizing toxicology by replacing animal testing with sophisticated human models, improving clinical trials through better prediction of long-term effects, improving manufacturing, preparedness for handling the evaluation of emerging technologies, compiling health data from multiple sources, food safety, addressing the threats of new and emerging diseases, and patient education.

"We have tremendous opportunities," Goodman concluded, "…but to really transform them into things that help people is going to require partnerships…We really welcome the University of Maryland and scientists present and future to join us in that."